Global HRQoL in patients with RRMS at baseline and 1 year after starting treatment with natalizumab as measured through the MusiQoL questionnaire
| Measure | EDSS improved n=6 | EDSS stable n=28 | P value | ||||
| Baseline | 1 year | Change | Baseline | 1 year | Change | Wilcoxon* | |
| MusiQoL index | |||||||
| Mean±SD, Median (min., max.) | 61.2±13.1 62.6 (41.4, 81.0) | 66.3±10.3 70.7 (50.0, 75.3) | 5.1±6.4 6.0 (–5.7, 12.7) | 67.9±14.2 69.0 (40.2, 94.4) | 70.8±17.7 71.8 (35.2, 97.9) | 2.9±12.1 2.0 (–28.1, 31.4) | 0.461 |
| Subdomains | |||||||
| Activity of daily living | |||||||
| Mean±SD Median (min., max.) | 56.8±21.8 60.9 (21.9, 81.3) | 69.8±21.8 65.6 (46.9, 100.0) | 13.0±19.4 12.5 (–9.4, 37.5) | 60.3±28.1 59.8 (3.1, 100.0) | 71.0±26.4 75.0 (12.5, 100.0) | 10.7±19.3 7.8 (–32.1, 68.8) | 0.805 |
| Psychological well-being | |||||||
| Mean±SD Median (min., max.) | 53.1±32.5 56.3 (0.0, 93.8) | 65.6±26.1 62.5 (31.3, 100.0) | 12.5±35.6 12.5 (–43.8, 50.0) | 66.7±25.9 71.9 (0.0, 100.0) | 75.5±24.2 82.3 (25.0, 100.0) | 8.9±27.8 6.3 (–50.0, 100.0) | 0.637 |
| Symptoms | |||||||
| Mean±SD Median (min., max.) | 56.3±15.8 56.3 (37.5, 81.3) | 71.9±18.9 68.8 (50.0, 100.0) | 15.6±11.7 12.5 (6.3, 37.5) | 64.3±27.4 68.8 (12.5, 100.0) | 69.4±27.4 71.9 (25.0, 100.0) | 5.1±15.9 0.0 (–25.0, 56.3) | 0.118 |
| Relationships with friends | |||||||
| Mean±SD Median (min., max.) | 54.2±27.3 54.2 (25.0, 83.3) | 54.2±24.6 50.0 (16.7, 91.7) | 0.0±23.6 0.0 (–33.3, 25.0) | 50.3±28.1 50.0 (0.0, 100.0) | 53.0±28.4 54.2 (0.0, 100.0) | 2.7±29.7 0.0 (–58.3, 75.0) | 0.874 |
| Relationships with family | |||||||
| Mean±SD Median (min., max.) | 58.3±23.6 58.3 (25.0, 83.3) | 56.9±27.6 54.2 (25.0, 100.0) | –1.4±30.5 –12.5 (–25.0, 58.3) | 78.3±23.3 83.3 (25.0, 100.0) | 72.9±24.3 75.0 (0.0, 100.0) | −5.4±26.7 0.0 (–100.0, 50.0) | 0.856 |
| Sentimental and sexual life | |||||||
| Mean±SD Median (min., max.) | 64.6±9.4 62.5 (50.0, 75.0) | 66.7±15.1 68.8 (50.0, 87.5) | 2.1±20.0 −6.3 (-12.5, 37.5) | 58.5±32.1 68.8 (0.0, 100.0) | 56.7±34.8 56.3 (0.0, 100.0) | −1.8±22.0 0.0 (–50.0, 62.5) | 0.782 |
| Coping | |||||||
| Mean±SD Median (min., max.) | 60.4±35.7 75.0 (0.0, 87.5) | 66.7±38.5 75.0 (0.0, 100.0) | 6.3±28.2 6.3 (–37.5, 50.0) | 67.0±30.8 75.0 (0.0, 100.0) | 72.8±26.8 81.3 (12.5, 100.0) | 5.8±27.1 6.3 (–87.5, 62.5) | 0.963 |
| Rejection | |||||||
| Mean±SD Median (min., max.) | 79.2±18.8 87.5 (50.0, 100.0) | 87.5±19.4 93.8 (50.0, 100.0) | 8.3±21.9 0.0 (–12.5, 50.0) | 83.0±22.9 93.8 (25.0, 100.0) | 83.5±23.8 100.0 (25.0, 100.0) | 0.4±20.5 0.0 (–75.0, 50.0) | 0.683 |
| Relationships with healthcare systems | |||||||
| Mean±SD Median (min., max.) | 68.1±17.0 70.8 (41.7, 91.7) | 61.1±17.2 66.7 (33.3, 75.0) | –6.9±14.4 –4.2 (–33.3, 8.3) | 82.7±14.7 75.0 (41.7, 100.0) | 82.7±17.1 83.3 (33.3, 100.0) | 0.0±23.6 0.0 (–66.7, 58.3) | 0.498 |
The nine subscores of the MusiQoL evaluate specific components of HRQoL. Patients with RRMS were grouped according to disability status on the EDSS. ‘EDSS improvement’ was defined as ≥1.0-point decrease in EDSS score sustained for at least 12 weeks, and ‘EDSS stable group’ was defined as changes in EDSS scores sustained for <12 weeks or with changes <1.0. ‘EDSS progression’ was defined as ≥1.0-point increase sustained for at least 12 weeks. The EDSS worsened patient (n=1) was not included in this analysis as per post hoc analysis plan.
*Assessment of differences between the ‘EDSS improved’ or ‘EDSS stable’ groups in change from baseline to 1 year.
EDSS, Expanded Disability Status Scale; HRQoL, health-related quality of life; MusiQoL, Multiple Sclerosis International Quality of Life; RRMS, relapsing-remitting multiple sclerosis.